Study of Secutrelvir in Participants With COVID-19

NCT07746544 | Not Yet Recruiting Phase 3

• 1 other identifier: 2512T1631
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of this study is to compare secutrelvir to placebo with respect to resolution of clinical symptoms in nonhospitalized participants with Coronavirus Disease 2019 (COVID-19) starting intervention within 48 hours of COVID-19 symptom onset.

Conditions

COVID-19

Keywords

S-892216; SARS-CoV-2; Mpro; Main Protease; Nonstructural Protein 5; nsp5

Outcome Measures

Primary Outcomes (1)

• Time to First Resolution of 14 Protocol-defined Symptoms of COVID-19 Through Day 21

  Symptoms will be assessed by the investigator via a participant daily electronic diary.

  Baseline through Day 21

Secondary Outcomes (13)

• Time to Sustained Resolution of 14 Protocol-defined Symptoms of COVID-19 Through Day 28

  Baseline through Day 28

• Time to Sustained Resolution of 14 Protocol-defined Symptoms of COVID-19 Through Day 21

  Baseline through Day 21

• Time to First Resolution of 14 Protocol-defined Symptoms of COVID-19 Symptoms Through Day 28

  Baseline through Day 28

• Time to First Alleviation of 14 Protocol-defined Symptoms of COVID-19 Through Day 21

  Baseline through Day 21

• Time to Sustained Alleviation of 14 Protocol-defined Symptoms of COVID-19 Through Day 21

  Baseline through Day 21

Study Arms (2)

Secutrelvir

EXPERIMENTAL

Participants will receive secutrelvir administered orally.

Drug: Secutrelvir

Placebo

PLACEBO COMPARATOR

Participants will receive placebo administered orally.

Drug: Placebo

Interventions

Secutrelvir DRUG

Secutrelvir will be administered orally as a tablet.

Also known as: S-892216

Secutrelvir

Placebo DRUG

Placebo will be administered orally as a tablet.

Placebo

Eligibility Criteria

• Age: 12 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be 12 to \< 18 years of age (where permitted by local regulation) with a body weight ≥ 40 kilograms (kg), or ≥ 18 and \< 75 years of age regardless of body weight, at the time of signing the informed consent form (ICF).
• Must have ≥ 1 of the protocol-defined COVID-19 symptoms of moderate or severe, present within 24 hours prior to randomization.
• Confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection as determined by any SARS-CoV-2 test, collected ≤ 48 hours prior to randomization.
• Must be randomized within 48 hours of COVID-19 symptom onset, defined as the time when the first COVID-19 symptom occurs.
• Agrees not to participate in another clinical study for the treatment of COVID-19 until completion of the study.

You may not qualify if:

• Current need or anticipated need for hospitalization within 24 hours, due to signs of severe COVID-19 illness or due to other medical conditions requiring hospitalization in the opinion of the site investigator.
• Documented respiratory infection (for example, influenza, respiratory syncytial virus infection) other than COVID 19 within 14 days prior to the screening visit.
• Known history of cirrhosis or liver decompensation (including ascites, variceal bleeding, or hepatic encephalopathy).
• Suspected or confirmed COVID-19 outside of the current episode within 3 months of randomization.
• Suspected or confirmed concurrent active systemic infection other than COVID-19 that may interfere with the evaluation of response to the investigational intervention.
• Ongoing long COVID or postacute sequelae of COVID (PASC) diagnosis.
• Current severely immunocompromised conditions.
• Received or expected to receive any other COVID-19-specific therapies.
• Have previously received secutrelvir.
• Exposed to an investigational drug within 30 days or 5 half-lives (whichever is longer) prior to the screening visit.

Sponsors & Collaborators

• Shionogi: lead

Study Sites (1)

Japanese Site 1

Multiple Locations, Japan

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Shionogi Clinical Trials Administrator Clinical Support Help Line

CONTACT

1-800-849-9707; Shionogiclintrials-admin@shionogi.co.jp

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2026
• First Posted: August 5, 2026
• Study Start: July 20, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: August 5, 2026

Record last verified: 2026-08

Locations

JP (1)